PL EN

EMA: Concept paper on the need for a single note for guidance on the chemistry of active substances

20.02.2014
This concept paper addresses the need to update and revise the guidance available on the chemistry of the active substance. There are currently two approved guidelines on the subject; CPMP/QWP/130/96, Rev1 Note for guidance on the chemistry of new active substances and 3AQ5a, chemistry of the active substance.

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